Protocol summary

Summary
Objectives: This study aims at the effects of group logo therapy on Coping Strategies with Stress, adjustment and life expectation on leukemia patients and comparing the results to those of control group. Design: This study is a semi-experimental research based on pre-test and post-test with a control group. Research population consists of all leukemia patients. From the above-mentioned population, 16 subjects have been selected through available non-random sampling. Setting and conduct: Subjects are divided into two experimental and control groups in a random manner. Then, subjects in the experimental group are being trained for logo therapy in 10 sessions. Subjects in control group will not receive any training. Major Inclusion and Exclusion criteria: Diagnosis of leukemia in the subjects, Self awareness from cancer, high education are of criteria for entering into the study. Accompanied diseases (such as other cancer), Lack of knowledge regarding the disease and lack of inclination of patients for attending at intervention sessions are of criteria for exiting from the study. Interventions: Subjects in both experimental and control groups will be initially tested using measuring tools for coping strategies, hope and adjustment. Then, subjects in the experimental group are being trained for “logo therapy” and will be post-tested for the extent of change in coping strategies, hope and adjustment and compared to those in control group. Main outcome measures: coping strategies, hope and adjustment are elementary consequent variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050615590N3
Registration date: 2015-09-04, 1394/06/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Mansoor Beyrami
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 313 4470
Email address
m.bayrami@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hematology and Oncology Research , Tabriz University of Medical Scienc
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
group logo therapy on Coping Strategies with Stress, adjustment and life expectation on leukemia patients and comparing with control group= Effectiveness study
Public title
logo therapy on leukemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of leukemia; Self awareness from cancer; high education in patients Exclusion criteria: Have other disease (for example: other kind of cancer); Lack of knowledge regarding the disease; lack of inclination of patients for attending at intervention sessions
Age
From 28 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects are divided into two experimental and control groups in a random manner with their document number.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee for Ethics in biomedical research of Tabriz University of Medical Science
Street address
4tth office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
TBZMED.REC.1394.500

Health conditions studied

1

Description of health condition studied
leukaemia
ICD-10 code
C90.1, C92
ICD-10 code description
Plasma cell leukaemia, Myeloid leukaemia, Monocytic leukaemia , Other leukaemias of specified cell type , Leukaemia of unspecified cell type

Primary outcomes

1

Description
Coping style with stress
Timepoint
Before treatment and 1 week after
Method of measurement
Coping Style Questionnaire

2

Description
Adaptation with illness
Timepoint
Before treatment and 1 week after
Method of measurement
Adaptation with Illness Questionnaire

3

Description
life expectation
Timepoint
Before treatment and 1 week after
Method of measurement
Hope Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Experiment group will intervened with logo therapy in 10 sessions. The component of intervention is: Knowing about cancer, coping with stress, Relaxation, adaptation with illness and knowing about increasing hope
Category
Behavior

2

Description
Control group do not receipt any treatment program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Pari Ghaem
Street address
2th office, First Floor, Ghazi Hospital, Tabriz University of Medical Science, Golghasht Street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Jamal Eyvazi
Street address
3rth office, First Floor, Ghazi Hospital, Tabriz University of Medical Sciences, Golghasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
PhD Student in Tabriz University
Other areas of specialty/work
Street address
Child Psychology Office, Fourth Floor, Milad building, Corner of Mlli Bank, 17 Shahrivar Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3557 5849
Fax
Email
shirinzeinali@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Mansoor Beirami
Position
PhD
Other areas of specialty/work
Street address
Fourth Floor, Faculty of Psychology, Tabriz University, Emam Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3339 2083
Fax
Email
m.bayrami@tabrizu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Shirin Zeinali
Position
Phd Student
Other areas of specialty/work
Street address
Faculty of Psychology, Tabriz University, Emam Street, Tabriz
City
Tabriz
Postal code
5186843636
Phone
+98 41 3554 6901
Fax
Email
shirinzeinali@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...